OraSure seeking OK for self-swab
Company hopes FDA will approve rapid test for public use
OraSure Technologies Inc. has developed a COVID19 rapid self-test in which a person swabs their lower nostrils, swirls the test stick in a pre-measured solution and then gets the result a short time later.
Before the test can get to market, the Bethlehem company needs the OK from the U.S. Food and Drug Administration.
OraSure on Tuesday announced it has submitted an application to the FDA for emergency use authorization of its rapid antigen test for prescription home use and professional use. The professional test would be used at drive-thru sites, doctors’ offices and public health sites, while the prescription test is for at-home use by consumers with a prescription.
“We believe our rapid antigen tests will be well received in the market thanks to their simplicity and ease of use,” President and CEO Stephen Tang said in a news release. “We also have the proven experience and capabilities to manufacture at scale to meet demand. With the race between vaccines and variants ongoing, testing will continue
to play a crucial role in reopening workplaces, schools and other places where people gather.”
The submission to the FDA was expected, after OraSure on March 1 said it had finalized all product development and completed clinical studies for the test and planned to seek emergency use authorization by the end of the month. While it’s hard to forecast the duration of the FDA’s review, Tang told The Morning Call earlier this month that process could take in the ballpark of six to eight weeks.
As of Tuesday, the FDA has granted emergency use authorization to 349 tests and sample collection devices, but that includes only a handful of at-home tests, including two antigen prescription tests, one molecular prescription test and one over-the-counter antigen test. For that reason and others, OraSure believes significant opportunity remains for at-home testing in the United States and internationally as the bumpy vaccination rollout continues.
OraSure has been working on the test for a year and last April announced it had won a $710,000 federal contract to develop a COVID-19 in-home test. The company, at that time, anticipated a development cycle of about four to six months, hoping to bring the test to market by late summer or early fall.
Now, in parallel with the FDA submission, the company is in the midst of a manufacturing capacity expansion that is bringing jobs to the Lehigh Valley. That follows an event in August in Harrisburg, when OraSure joined state officials to announce a $7.5 million expansion in the Lehigh Valley that would help the firm keep pace with anticipated demand.
Construction is ongoing at the company’s location in South Side Bethlehem to build the manufacturing lines. The expansion is expected to create 177 full-time jobs and retain 233 positions across three OraSure locations in Bethlehem and one in Bethlehem Township.
Right now, OraSure has the annual capacity to manufacture 55 million rapid tests a year, output that includes 17 million units for its tests for HIV, Ebola and the hepatitis C virus.
The company plans to boost that annual capacity to 70 million tests per year by the third quarter of this year and then to 120 million tests by the second quarter of 2022.
OraSure, according to its annual report, plans to manufacture its COVID-19 rapid antigen self-test at its Bethlehem facilities and, to supply certain international markets, at a thirdparty site in Thailand.
OraSure has not announced a specific price for its self-test, but the company has pointed to a reimbursement code for a similar product, and that is in the range of $41.
The company’s stock closed at $11.11 on Tuesday, up 1.2% from Monday.